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MeCross CTO PTCA Balloon Dilatation Catheter

by Shenzhen Medoo Medical Tech. Co., Ltd

Ref MC-01-1010Model MC-01-1010, MC-01-1015, MC-01-1020, MC-01-1030, MC-01-1210, MC-01-1215, MC-01-1220, MC-01-1230,MC-01-1510,MC-01-1515,MC-01-1520,MC-01-1530,etc

Active European Union

CE MDR

Valid until

18 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697371064MC01H5 Basic UDI-DI 06973710640016UDI-DIDate22 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 786405 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    19 Mar 2025
    Expires
    18 Mar 2030

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED

Device Name
MeCross CTO PTCA Balloon Dilatation Catheter
Model / Reference
MC-01-1010, MC-01-1015, MC-01-1020, MC-01-1030, MC-01-1210, MC-01-1215, MC-01-1220, MC-01-1230, MC-01-1510, MC-01-1515, MC-01-1520, MC-01-1530, etc
Primary DI / UDI-DI
06973710640016
Basic UDI-DI
697371064MC01H5
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000011452
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Medoo Medical Tech. Co., Ltd

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No